Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific Meal
This study has been completed.
Sponsor:
AstraZeneca
Collaborators:
Scentryphar Clinical Research
Cori Analyticals
Clínica São Lucas, Hospital Sírio Libanês de Itatiba S/C
LabClin Laboratório Clínico
Laboratório de Patologia Clínica Dr. Franceschi Ltda.
Faculdade de Ciências Farmacêuticas de Ribeirão Preto - Centro de Bioequivalência
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00905333
First received: May 19, 2009
Last updated: December 6, 2010
Last verified: December 2010
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Purpose
The purpose of this study is to evaluate the pharmacokinetic interaction of test formulations of candesartan and felodipine in a combination package comparing with the fasting intake of commercial formulations of both Atacand ® and Splendil®
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Candesartan (test) Drug: Felodipine (test) Drug: Candesartan Cilexetil Drug: Felodipine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine in a Combination Package Compared to the Separate Intake of the Reference Brands Atacand and Splendil After a Fasting Period. |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Kinetic interaction evaluation of two test formulations of 16 mg of candesartan and 5 mg of felodipine after a fasting period and the comparison with the intake of both reference medicaments: Atacand® and Splendil®. [ Time Frame: 76 blood samples per subject ] [ Designated as safety issue: Yes ]
| Enrollment: | 36 |
| Study Start Date: | October 2008 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Single-arm
3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan)
|
Drug: Candesartan (test)
16 mg oral tablet, single dose
Drug: Felodipine (test)
5 mg oral extended release tablet, single dose
Drug: Candesartan Cilexetil
16 mg oral tablet, single dose
Other Name: Atacand®
Drug: Felodipine
5 mg oral extended release tablet, single dose
Other Name: Splendil®
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy volunteers
- BMI > or = 19 and < or = 28 (Dietary Guidelines Advisory Committee, 2005)
Exclusion Criteria:
- Not healthy
- Chronic drug intake
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905333
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905333
Locations
| Brazil | |
| Research Site | |
| Itatiba, SP, Brazil | |
| Research Site | |
| Americana, Brazil | |
Sponsors and Collaborators
AstraZeneca
Scentryphar Clinical Research
Cori Analyticals
Clínica São Lucas, Hospital Sírio Libanês de Itatiba S/C
LabClin Laboratório Clínico
Laboratório de Patologia Clínica Dr. Franceschi Ltda.
Faculdade de Ciências Farmacêuticas de Ribeirão Preto - Centro de Bioequivalência
Investigators
| Principal Investigator: | Eduardo Abib Junior, MD | Scentryphar Clinical Research |
| Study Chair: | Moises L. P Vanuncci, MD | Scentryphar Clinical Research |
More Information
| Responsible Party: | MC MD, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00905333 History of Changes |
| Other Study ID Numbers: | D2452L00021 IMPACT 15381 |
| Study First Received: | May 19, 2009 |
| Last Updated: | December 6, 2010 |
| Health Authority: | Brazil: Ethics Committee Brazil: National Health Surveillance Agency |
Keywords provided by AstraZeneca:
|
pharmacokinetics candesartan felodipine test formulations Atacand® |
Splendil® healthy volunteers blood samples after meal intake interaction Kinetic interaction amongst test formulations of Candesartan and Felodipine and the brands Atacand® and Splendil® in healthy volunteers after a fasting period. |
Additional relevant MeSH terms:
|
Candesartan Candesartan cilexetil Felodipine Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Calcium Channel Blockers Membrane Transport Modulators Vasodilator Agents |
ClinicalTrials.gov processed this record on September 30, 2016